IOL insertion apparatus and method for making and using same

ABSTRACT

Apparatus for inserting intraocular lenses (IOLs) into eyes include a hollow tube including a material and having an interior wall defining a hollow space through which an IOL is passed and an outlet through which the IOL is passed from the hollow space into an eye, and a lubricity enhancing component physically secured to said hollow tube and concentrated at or near the interior wall in an amount effective to facilitate the passage of the IOL through the hollow space.

RELATED APPLICATIONS

The application is a division of application Ser. No. 10/077,615, filedFeb. 15, 2002, now U.S. Pat. No. 6,679,891 which is a division ofapplication Ser. No. 09/535,267, filed Mar. 23, 2000, now U.S. Pat. No.6,398,788, issued Jun. 4, 2002, which is a division of application Ser.No. 09/236,541, filed Jan. 25, 1999, now U.S. Pat. No. 6,083,230, issuedJul. 4, 2000, which is a division of application Ser. No. 08/903,282,filed Jul. 30, 1997, now U.S. Pat. No. 5,942,277, issued Aug. 24, 1999,which is a division of parent application Ser. No. 08/676,699, filedJul. 10, 1996, now U.S. Pat. No. 5,716,364, issued Feb. 10, 1998.

BACKGROUND OF THE INVENTION

The present invention relates to apparatus for inserting an intraocularlens through a small incision into an eye, to methods for making suchapparatus and to methods for inserting an intraocular lens into an eye.More particularly, the invention relates to an apparatus which hasenhanced lubricity and is useful for inserting a foldable intraocularlens into an eye, to methods for making such apparatus and to methodsusing such apparatus to insert a foldable intraocular lens into an eye.

An intraocular lens (IOL) is implanted in the eye, for example, as areplacement for the natural crystalline lens after cataract surgery orto alter the optical properties of (provide vision correction to) an eyein which the natural lens remains. IOLs often include an optic, andpreferably at least one flexible fixation member or haptic which extendsfrom the optic and becomes affixed in the eye to secure the lens inposition. The optic normally includes an optically clear lens.Implantation of such IOLs into the eye involves making an incision inthe eye. It is advantageous, to reduce trauma and speed healing, to havean incision size as small as possible.

IOLs are known which are foldable (deformable) so that the IOL can beinserted through a smaller incision into the eye. A substantial numberof instruments have been proposed to aid in inserting such a foldablelens in the eye.

Many of the prior art IOL insertion systems load and/or fold the lens atthe distal end, that is at the end closest to the eye or the endinserted into the eye. Such “distal loading” systems oftendisadvantageously include a space consuming loading component at or nearthe distal end of the system which causes the distal end to berelatively large. This relatively large distal end makes inserting theIOL through a small incision more difficult, if not impossible. Systemswhich fold and load the IOL proximally of the distal end provide certainadvantages, such as reduced stress on the IOL and/or inserter, relativeto “distal loading” systems.

However, whether using a distal loading or proximal loading system, onefactor which limits the size of the inserter tube involves the insertertube itself. For example, the material from which the inserter tube ismade, for example, polypropylene and the like polymeric materials, maynot be compatible or otherwise susceptible to causing optics, forexample, made from silicone polymeric materials, to pass throughrelatively small hollow spaces. For example, the injector tubes may bemade of materials, in particular polymeric materials, which haveinsufficient lubricity to facilitate the passage of a folded IOL throughthe tube.

As a result of this lack of lubricity, the hollow space of the injectortube must be made relatively larger to accommodate the foldedintraocular lens. This is detriment since, as noted above, it isadvantageous to have the smallest possible incision for insertion of theIOL. In addition, if one were to use a small diameter tube to pass theIOL, excessive force might be needed to pass the IOL through the smallhollow space thereby increasing the risks of damaging the IOL and, inextreme cases, even damaging the eye into which the IOL is placed.

One approach that may be considered is to use a lubricity agent, forexample, such as conventional visco-elastic agents, in the hollow spaceof the tube to facilitate passing the IOL through the insertionapparatus. However, such lubricity agents in and of themselves occupyvaluable space, thereby at least partially defeating the purpose ofusing such agents Also, such lubricity agents often end up in the eye,thereby creating the risk of causing trauma and/or irritation and/ordamage to the eye.

It would be advantageous to provide straightforward IOL insertionapparatus and methods for using same which facilitate the passage offolded IOLs through the apparatus in a controlled manner without usingexcessive force.

SUMMARY OF THE INVENTION

New apparatus for injecting IOLs and methods for making and using suchapparatus have been discovered. The present apparatus achieve enhancedlubricity, thus providing for the use of effective, reliable andnon-excessive amounts of force to inject a folded IOL into an eye. Thepresent IOL inserter production methods provide inserters which havevery effective and reliable lubricity properties. The present inventionis easy to practice. The methods of use included in the presentinvention often involve surgical techniques which are well practiced andconventionally used to insert IOLs into eyes.

In general, the present invention involves apparatus for inserting IOLsinto an eye which include a lubricity enhancing component physicallysecured to the apparatus and concentrated at or near the interior wallor walls of the apparatus, for example, at or near the interior wall ofthe apparatus defining a hollow space through which an IOL is passed. Ithas been found that the inclusion of such a physically secured or bondedlubricity enhancing component is effective to facilitate the passage ofthe IOL through the apparatus. Physically securing or bonding suchlubricity enhancing components in or on the apparatus is particularlyeffective since the amount of such component present, and the degree ofenhanced lubricity obtained, is conveniently controlled and stable on along term basis, for example, the apparatus has a relatively long shelflife before use. Preferably, a reduced amount of the physically securedor bonded lubricity enhancing component passes into the eye during useof the present apparatus relative to a similar or substantiallyidentical apparatus on which the lubricity enhancing component is notbonded or secured to the apparatus.

In one embodiment, the present apparatus include an interior wall whichis a plasma-exposed interior wall. This plasma-exposed interior wallpreferably has an enhanced ability to physically secure or bond thelubricity enhancing component relative to a substantially identicalinterior wall which is not plasma-exposed. In one useful embodiment, theplasma-exposed interior wall facilitates forming the lubricity enhancingcomponent concentrated at or near the interior wall of the hollow tube.

In general, the present methods for producing IOL insertion apparatuscomprise exposing a hollow tube including a material and having aninterior wall defining a hollow space through which an IOL is passed andan outlet though which the IOL is passed from the hollow space into aneye to an effective plasma, and providing an effective amount of alubricity enhancing component at or near the interior surface. It hasbeen found that the combination of the exposing step and the providingstep is effective to facilitate the passage of the IOL through thehollow space.

The use of the present IOL insertion apparatus allows successfulinjection of silicone-based IOLs, for example, employing inserters madeof polypropylene and the like polymeric materials, through incisions ofabout 3.5 mm or about 3.2 mm or less, preferably about 3.0 mm or less,and still more preferably about 2.8 mm or less.

In one broad aspect of the present invention, apparatus for insertingIOLs through small incisions into eyes are provided. Such apparatuscomprise a hollow tube including (or made of) a material, preferably apolymeric material, and having an interior wall defining a hollow spacethrough which an IOL is passed and an outlet, preferably a distal endopening, through which the IOL is passed from the hollow space into aneye. A lubricity enhancing component, preferably selected fromhydrophilic components, oleophilic components and mixtures thereof, morepreferably selected from oleophilic components, other than the material,is physically secured or bonded to the hollow tube and concentrated ator near the interior wall. The hollow tube, and in particular theinterior wall, is preferably exposed to a plasma, more preferably asub-atmospheric pressure oxygen-containing plasma. The combination ofthe lubricity enhancing component and exposing the interior wall of thehollow tube to plasma preferably is effective to facilitate the passageof the IOL through the hollow space. The lubricity enhancing componentpreferably is present in a minor amount, more preferably in the range ofabout 0.1% to about 1% or about 10% or about 20%, of the total weight ofthe hollow tube. The lubricity enhancing component is physicallysecured, for example, physically bonded, admixed or combined, to theother material making up the hollow tube using methods known in the art,such as by blending or mixing the lubricity enhancing component andother material prior to forming the hollow tube and/or forming a coatingof lubricity enhancing components on the already formed hollow tube.

By “physically” securing or bonding is meant a non-covalent chemicalbonding joining or coupling, and preferably a non-chemical bonding,joining or coupling. Some interaction, for example, ionic and/orelectrical interactions may occur between the lubricity enhancingcomponent and the other material or materials making up the hollow tube.However, the present “physical” securing or bonding is clearlydistinguished from forming covalent chemical-bonds between the lubricityenhancing component and the other material or materials making up thehollow tube. The prior art has suggested providing covalent chemicallybonded lubricants to avoid losing the lubricant during use. It has nowbeen found that physically secured or bonded lubricity enhancingcomponents have a reduced tendency to be lost (from the IOL inserter)during use of the present IOL inserters. Thus, physically securing orbonding the lubricity enhancing component to the hollow tube is anysuitable coupling or joining which is not covalent chemical bonding ofthe lubricity enhancing component is the other material of the hollowtube.

In a particularly useful embodiment, the lubricity enhancing componentis effective to reduce the force needed to pass the IOL through thehollow space of the tube relative to the force needed to pass anidentical IOL through the hollow space of a similar apparatus withoutthe lubricity enhancing component. This “reduced force” feature of thepresent invention is particularly useful, even when no reduction in thesize of the incision is obtained. The use of reduced force allows thesurgeon to have more control of the rate at which the IOL is insertedinto the eye and, in addition, reduces the risk of damage to the eyeduring IOL insertion.

The material from which the hollow tube preferably is made is apolymeric material, for example, a hydrophobic polymeric material, morepreferably selected from polyolefins, such as polypropylene and the likematerials.

In one useful embodiment, the present apparatus further comprises aloading portion including a material and having an internal walldefining a chamber sized and adapted to receive an IOL for passage intothe hollow space. A further lubricity enhancing component, preferablyanother amount of the same lubricity enhancing component employed in thehollow tube, preferably is physically secured to the loading portion andconcentrated at or near the internal wall of the loading portion. Thisfurther lubricity enhancing component is effective to facilitate thepassage of an IOL into the hollow space. The internal wall of theloading portion preferably is exposed to a further plasma, preferablythe same plasma used with the hollow tube. In one embodiment, thecombination of the further lubricity enhancing component and the furtherplasma is effective to further facilitate the passage of the IOL intothe hollow space. Both the interior wall of the hollow tube and theinternal wall of the loading portion preferably include effectiveamounts of the lubricity enhancing component and are exposed to plasmato facilitate passage of the IOL from the loading portion into thehollow tube and from the hollow tube into the eye. In addition, it isoften more convenient to treat both the hollow tube and loading portion,which together preferably are a single, integrally formed unit, with thelubricity enhancing component and plasma, rather than treating only thehollow tube.

The loading portion preferably is sized and adapted to receive an IOL,for example, in an unfolded state, and to hold the IOL in a foldedstate. The loading portion can be structured to at least facilitate thefolding of the IOL from the unfolded state to a folded state. The hollowtube includes an interior wall which defines a hollow space preferablysized to receive the IOL in a folded state from the loading portion andto pass the folded IOL to an open outlet through which the IOL is passedinto an eye.

Methods for producing apparatus for inserting an IOL through a smallincision in the eye are provided and are included within the scope ofthe present invention. These methods have, in general, been discussedabove, and comprise exposing a hollow tube to plasma and providing aneffective amount of a lubricity enhancing component physically securedto said hollow tube and concentrated at or near the interior wall of thehollow tube. More specifically, the plasma employed is preferably asub-atmospheric pressure plasma, more preferably a sub-atmosphericpressure, oxygen-containing plasma, although other plasmas are suitable.

As used herein, the term “concentrated” means that the lubricityenhancing component is located in a higher concentration at or near oneor more portions, for example, the surfaces, of an article than at oneor more other portions, for example, the interior, of the article. Thisincludes the situation in which the lubricity enhancing component islocated as a coating on the interior surface of the hollow tube and isnot present in the hollow tube itself. Also included is a situation inwhich the hollow tube includes a concentration of lubricity enhancingcomponent throughout with a locally higher concentration present at ornear the interior surface of the hollow tube.

In one embodiment, the lubricity enhancing component is physicallysecured or bonded to the hollow tube prior to the exposing step. In aparticularly useful embodiment, the providing step includes subjectingthe hollow tube having an amount of lubricity enhancing component spacedapart from the interior wall to conditions effective to cause thisamount of lubricity enhancing component to form at least a portion ofthe effective amount of the lubricity enhancing component at or near theinterior wall. For example, the hollow tube can be subjected to elevatedtemperatures for substantial periods of time, such as on the order ofabout 6 hours or about 12 hours to about 100 hours or more, to cause thelubricity enhancing component to move toward the surface. This“blooming” action is very effective in providing the desired amount oflubricity enhancing component concentrated at or near the interior wallof the hollow tube.

In addition, the loading portion can be formed by comparable exposingand providing steps.

Methods for inserting an IOL into an eye are also provided and areincluded within the scope of the present invention. In one embodiment,such methods comprise placing an outlet or distal end opening of thehollow tube of the present apparatus in or in proximity to an incisionin an eye, and passing art IOL from the hollow tube through the outletor opening into the eye.

These and other aspects of the present invention will become apparent inthe following detailed description and claims, particularly whenconsidered in conjunction with the accompanying drawings in which likeparts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front side view, in perspective, of an apparatus inaccordance with the present invention with the load chamber in the openposition.

FIG. 2 is a fragmentary, schematic illustration of a small portion ofthe apparatus shown in FIG. 1.

FIG. 2A is a fragmentary, schematic illustration of a small portion of amodified embodiment of the apparatus shown in FIG. 1 which includes acoating.

FIG. 3 is a side view, in perspective, of the apparatus shown in FIG. 2with the load chamber in the closed position.

FIG. 4 is a front side view, in perspective, of the apparatus shown inFIG. 3 loaded into a hand piece.

FIG. 5 is a side view, partly in cross-section, taken generally alongline 5-5 of FIG. 4.

FIG. 6 is a somewhat schematic illustration showing the apparatus shownin FIG. 4, with the hand piece partially in cross-section, being used toinsert an IOL into an eye.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an IOL inserter, shown generally at 10, including aload chamber 12 and an injection tube 14. The IOL inserter 10 is made ofpolypropylene to which has been physically added an amount, for example,in the range of about 0.1% to about 5% by weight of the inserter, of alubricity enhancing component, for example, an oleophilic component suchas glycerol monostearate or a hydrophilic component such aspolyvinylpyrrolidone.

The lubricity enhancing component is physically admixed with the othermaterial from which the inserter 10 is made, preferably prior to formingthe inserter. In a particularly useful embodiment, the lubricityenhancing component is combined with the other material, for example, apolymeric material, such as polypropylene, while the material is in themolten or fluid state. The lubricity enhancing component can be blendedin this material so that it is substantially uniformly distributedthroughout the material. The material is then placed in a mold orsimilar device suitable for forming the inserter 10. After the inserter10 is formed, the lubricity enhancing component remains substantiallyuniformly distributed throughout the inserter.

Once the inserter 10 is formed, it is processed to provide enhancelubricity. The inserter 10 is exposed to an effective plasma. Forexample, the inserter 10 can be placed in a chamber containing a plasma.The plasma may have its origin for any of a variety of materials,preferably gases, in particular gases such as oxygen, helium, nitrogen,argon and mixtures thereof. More preferably an oxygen-containing plasmais used.

In accordance with one embodiment of the present invention, radiofrequency, inductively-coupled plasma is produced in a plasma chamber bycharging the chamber with gas, e.g., oxygen, preferably at asub-atmospheric pressure such as about 0.01 torr (mm Hg) or greater,more preferably at a pressure in the range of about 0.01 torr to about0.3 torr or about 0.5 torr or about 1.0 torr. The preferred output poweris in the range of about 10 watts to about 600 watts.

The inserter 10 is preferably exposed to the plasma for a period of timein the range of about 15 seconds to about 120 minutes and morepreferably about 30 seconds to about 100 minutes. However, the specificgas, exposure time, power and/or other parameters may be varieddepending upon the equipment and the particular inserter and insertercomponents involved, and can be readily optimized based on thedisclosure herein using routine experimentation.

Although the present invention is not limited to any particularmechanism, and without limiting the present invention to any particulartheory of operation, the present methodology is believed to cause amodification or alteration, for example, a physical and/or chemicalmodification or alteration, of the exposed regions of the inserter,which, in turn, results in enhanced lubricity.

In addition, inserter 10 is subjected to conditions effective to form aninterior wall on or near which is present a higher concentration oflubricity enhancing component relative to the lubricity enhancingcomponent concentration present in the interior of the inserter. Aparticularly useful embodiment involves subjecting the inserter to anelevated temperature for a time effective to cause the lubricityenhancing component to migrate toward the surfaces, for example, theinterior surface, of the inserter. A common name for this phenomenon is“blooming”. Preferably, the inserter 10 is subjected to elevatedtemperatures of at least about 35° C., more preferably in the range ofabout 40° C. or about 45° C. to about 100° C. or about 120° C., for atime in the range of about 6 hours to about 150 hours and morepreferably in the range of about 8 hours to about 120 hours.

Again, without wishing to limit the invention to any particular theoryof operation, it is believed that this “blooming” step causes a portionof the lubricity enhancing component present in the inserter 10 to belocated at or near the interior surface of the inserter. However, it isalso believed that this lubricity enhancing component at or near theinterior surface of the inserter is physically, rather than covalentchemically, secured or bound to the inserter. However, it has been foundthat both the “blooming” step and the plasma exposing step, incombination, are very advantageous to provide enhanced lubricity to theinserter. In other words, an inserter which has only been subjected tothe “blooming” step or which has only been subjected to the plasmaexposing step provides substantially less advantageous results than ifthe inserter is subjected to both the “blooming” step and the plasmaexposing step.

Alternately, the inserter 10 can be formed and then treated with alubricity enhancing component, preferably selected from oleophiliccomponents, hydrophilic components and mixtures thereof. For example,the inserter 10 can be immersed in or sprayed with a lubricity enhancingcomponent or a medium, such as an aqueous medium, including a lubricityenhancing component one or more times so as to provide a surfacecoating, preferably a substantially uniform surface coating of thelubricity enhancing component, for example, on the interior surfaces orwalls of the inserter. The inserter 10 is exposed to a plasma, asdiscussed elsewhere herein, either prior to or after, preferably priorto, providing a surface coating of lubricity enhancing component.

In any event, the lubricity enhancing component is present in an amounteffective, in combination with the plasma exposing step, to enhance orfacilitate the passage of the IOL through the inserter 10 into the eye.It should be noted that the lubricity enhancing component need not besubstantially present within the inserter 10 as discrete particles.However, substantially no covalent chemical bonds exist between thelubricity enhancing component and the other material-making-up theinserter 10.

The lubricity enhancing components useful in the present invention maybe selected from suitable components which function as described herein.Although the lubricity enhancing component is preferably inhibited frompassing into the eye during use of the present apparatus, lubricityenhancing components which are substantially non-irritating to oculartissue and/or are substantially biocompatable with ocular tissue areparticularly useful in accordance with the present invention. Thelubricity enhancing component is present in an amount effective toenhance the lubricity of the interior wall of the hollow tube defining ahollow space through which the IOL passes in being inserted into theeye. Such lubricity enhancing components are preferably effective toprovide such enhanced lubricity for relatively long periods of time, forexample, for at least about 1 month or at least about 3 months or atleast about 6 months, so that the IOL inserter has a relatively longshelf life and can be used after being packaged and stored for suchrelatively long periods of time and still obtain the substantialenhanced lubricity benefits.

The physical securing or bonding of the lubricity enhancing component tothe IOL inserter preferably is effective to reduce the amount of thiscomponent which is passed into the eye as the IOL is inserted into theeye. In other words, it is preferred that such physical securing orbonding is effective to inhibit the lubricity enhancing component frompassing into the eye as the IOL is inserted into the eye. Thus, thepresent invention conveniently provides for enhanced lubricity and easeof inserting an IOL into an eye while, at the same time, reducing theamount of lubricity enhancing component in the eye and eliminating theneed for any covalent chemical reaction or reactions between thematerial of the inserter and the lubricity enhancing component.

Particularly useful oleophilic components include, but are not limitedto, those selected from carboxylic acids having about 10 to about 30,carbon atoms per molecule, glycerol esters of such carboxylic acids,such as glycerol monostearate, glycerol monopalmitate, glycerolmonooleate and the like, and mixtures thereof.

Particularly useful hydrophilic lubricity enhancing components include,but are not limited to, those selected from polyethylene glycol,polyvinylpyrrolidone, poly (N-vinyl lactams), polyacrylic acid,polyethylene oxide, polypropylene oxide, polyvinyl pyridine, polyvinylalcohol, polysaccharides, carboxy methyl cellulose, hydroxy alkylcelluloses, such as hydroxypropylmethyl cellulose and the like,polymethacrylic acid, polyacrylamide, polypeptides, poly sodium styrenesulfonate, polyhydroxyethyl methacrylate, heparin and the like andmixtures thereof. If a hydrophilic lubricity enhancing component isemployed, it is preferred that the IOL inserter be immersed or otherwisecontacted with water, for example, a saline solution, to hydrate thehydrophilic component. Such hydration is effective to facilitate thelubricity enhancing characteristics of the hydrophilic component.

In addition to the physically secured or bonded lubricity enhancingcomponent, the inserter 10 may also include a covalently bondedlubricity enhancing component, for example, as a coating on the exposedsurfaces, such as the interior surfaces of the inserter. Such additionalcovalently bonded lubricity enhancing component is effective to furtherenhance the lubricity of inserter 10. The covalently bonded lubricityenhancing component can be included in or on the inserter 10 in anysuitable manner.

FIGS. 1 and 3 to 6 illustrate the use of IOL inserter including aneffective amount of physically secured or bonded lubricity enhancingcomponent 19 (FIG. 2) or 20 (FIG. 2A) concentrated at or near theinterior surfaces thereof.

The body of IOL inserter 10 is an integrally formed, for example,molded, unit made primarily of propropylene. Load chamber 12 includes afirst member 16 and a second member 18 which are secured or joinedtogether and are hingeably moveable relative to each other along line21, which is parallel to the longitudinal axis 30 of inserter 10.

Injection tube 14 includes a proximal end portion 22, a distal endportion 24 and an open distal end 26. A reinforcing collar 28 iscoincidental with the proximal end portion 22 of injection tube 14.

Open distal end 26 is beveled at an angle of about 45° relative to thelongitudinal axis 30 of the inserter 10.

Injection tube 14 includes a through slot 32 which extends from the opendistal end 26 distally and terminates prior to the proximal end portion22 of injection tube 14. Through slot 32 is elongated in a directionparallel to the longitudinal axis 30 of inserter 10.

As shown in FIG. 1, inserter 10 is in the opened position. In contrast,in FIG. 3, inserter 10 is shown in the closed position. In the closedposition, the load chamber 12 includes a top 32 which is a combinationof top surfaces 34 and 36 of first wing 38 and second wing 40,respectively, of first member 16 and second member 18, respectively.First and second wings 38 and 40 are effective for a human user ofinserter 10 to hold and manipulate the inserter 10 while using it, asdescribed hereinafter.

Inserter 10 is described in more detail with reference to FIG. 4, whichshows the inserter in combination with hand piece 50. When used incombination with hand piece 50, the load chamber 12 of inserter 10 is inthe closed position, as shown in FIG. 4. With the load chamber 12 in theclosed position, and top 32 being the uppermost portion of the loadchamber, open distal end 26 of injection tube 14 is beveled at an angleof 45° relative to the longitudinal axis 30 of the inserter 10 so thatthe open distal end is generally right facing (when the inserter isviewed from above). In addition, through slot 32 intersects the opendistal end 26 at the proximal most portion of the open distal end, asshown in FIGS. 1, 3 and 5.

Referring to FIG. 5, with load chamber 12 in the closed position, theload chamber includes an interior wall 51 which defines a first lumen 52that is elongated in a direction parallel to the longitudinal axis 30 ofinserter 10. Injection tube 14 includes a tapering interior wall 53which defines a distally tapering second lumen 54. The averagecross-sectional area of second lumen 54 transverse to the longitudinalaxis 30 is smaller than or reduced relative to the averagecross-sectional area of the first lumen 52.

The first lumen 52 is aligned with the second lumen 54 so that a foldedIOL in the first lumen can be passed directly from the first lumen intothe second lumen. The taper of proximal portion 58 of second lumen 54 ismore severe than the slight taper which exists in the distal portion 60of the second lumen. The more severe taper in the proximal portion 58 iseffective to further fold the IOL as the IOL is passed into the secondlumen 54. This further folding is advantageous because the furtherfolded IOL can be inserted into the eye through a smaller incision. Theenhanced lubricity resulting from the oleophilic component 19facilitates this further folding so that a reduced amount of force isrequired to further fold the IOL and/or the degree of further holding ofthe IOL can be increased so that ultimately, the IOL can be insertedthrough an even smaller incision. The oleophilic component 19 alsoadvantageously reduces the risk of tearing and/or otherwise damaging theIOL as the IOL is passed through the first lumen 52 and second lumen 54.

With reference to FIG. 4, inserter 10 is shown in combination with handpiece 70 and push rod member 72. Hand piece 70 includes a relativelylarge, elongated first through opening 74 and a relatively small,elongated second through opening 76. Hand piece 70 includes a throughbore 78 which extends from the proximal end 80 to the distal end 82 ofthe hand piece. The proximal end portion 84 of hand piece 70 includesthreads 86 which are adapted to engage and mate with threads 88 of theproximal segment 90 of push rod member 72. Rod element 92 of push rodmember 72 is adapted to pass through bore 78, first lumen 52, secondlumen 54 and out of open distal end 26. Hand piece 70 and push rodmember 72 are made of metal, such as surgical grade stainless steel orthe like metals.

Inserter 10 is operated and functions as follows. When it is desired toload an IOL into inserter 10, the inserter is placed, for example,manually placed, in a configuration as shown in FIG. 3. With loadchamber 12 in the opened position, an IOL, such as is shown generally at100, is placed, for example, using forceps, in between first and secondmembers 16 and 18. This placement is such that the anterior face 102 ofoptic 104 faces upwardly, as shown in FIG. 1. The optic 104 is made of asilicone polymeric material. The filament haptics 106 and 108 of IOL 100are located as shown in FIG. 1, so that the fixation members are locatedgenerally parallel to, rather than transverse, to the longitudinal axis30

With IOL 100 placed as shown in FIG. 1, first and second members 16 and18 are hingeably moved relative to each other, for example, by manuallybringing first and second wings 38 and 40 together, to place the loadchamber 12 in the closed position, as shown in FIG. 3. With load chamber12 in the closed position, IOL 100 is in a folded state, that is optic104 is folded. The relative movement of first and second members 16 and18 to move the load chamber from the open position to the closedposition is effective to fold the lens. The folded IOL 100 is nowlocated in the first lumen 52. For clarity sake, the folded IOL is notshown in any of FIGS. 3, 4, 5 or 6.

With the inserter 10 configured as shown in FIG. 3 and folded IOL 100located in first lumen 52, the inserter 10 is placed in association withhand piece 70, as shown in FIG. 4. In this configuration, the distal endportion 24 of injection tube 14 extends distally beyond the distal end82 of hand piece 70. As shown in FIG. 5, the distal portion 85 ofhand-piece 70 includes an inner wall 87 which is configured to receivereinforcing collar 28 in abutting relation.

With inserter 10 so placed relative to hand piece 70, push rod member 72is placed into the through bore 78 of the hand piece starting at theproximal end 80. As threads 88 come in contact with and engage threads86, the push rod member 72 is rotated, as shown in FIG. 6, so as tothread the push rod member onto the proximal end portion 84 of handpiece 70. By gradually moving push rod element 92 through bore 78 ofhand piece 70, the folded IOL 100 is urged to move from first lumen 52into second lumen 56, through open distal end 26 and into the eye.

Referring now to FIG. 6, the IOL 100 is to be placed in eye 120 into anarea formerly occupied by the natural lens of the eye. FIG. 6 shows thesclera 122 having an incision through which the distal end portion 24 ofinjection tube 14 is passed. Alternately, the incision can be madethrough the cornea. Distal end portion 24 has a sufficiently smallcross-section to pass into the eye 122 through a 3.0 mm incision in thesclera 122.

The injection tube 14 is manipulated within eye 122 until it ispositioned so that IOL 100 can be properly positioned in eye 122, thatis in the anterior chamber, the posterior chamber, the capsular bag 124or in the sulcus, after being released. Thus, the surgeon is able tocontrollably position the distal end portion 24 of injection tube 14,with IOL 100 in the first lumen 52 of load chamber 12. Once distal endportion 24 is so positioned, the rod element 92 is urged distally, byrotating (threading) push rod member 72 onto hand piece 70, to pass theIOL 100 into and through the second lumen 54, through the open distalend 26 of injection tube 14 and into the eye 120. The anterior face 102of IOL 100 faces generally forwardly in the eye 120 as the IOL isreleased from the inserter 10. In other words, the IOL 100 passesthrough first lumen 52, second lumen 54 and open distal end 26 and intoeye 120 without flipping or otherwise becoming mispositioned. Only arelatively small amount of, if any, post-insertion re-positioning isneeded to properly position IOL 100 in eye 120.

After the IOL 100 has been inserted into the eye, the rod element 92 ismoved proximally into the injection tube 14 and the distal end portion24 of the injection tube is removed from the eye. If needed, the IOL 100can be re-positioned in the eye by a small, bent needle or similar toolinserted into the same incision.

Once the IOL 100 is properly positioned in eye 120 and inserter 10 iswithdrawn from the eye, the incision in the sclera may be mended, forexample, using conventional techniques. After use, inserter 10 ispreferably disposed of. Hand piece 70 and push rod member 72 can bereused, after sterilization/disinfection.

The following non-limiting examples illustrate certain aspects of thepresent invention.

EXAMPLES

A series of IOL inserters, similar in configuration to inserter 10, wereprovided and tested.

These inserters were as follows:

-   INSERTER A: molded from polypropylene including 0.25% by weight of    glycerol monostearate distributed substantially uniformly    throughout. Inserter A was subjected to no plasma processing and no    blooming processing.-   INSERTER B: molded from polypropylene including 0.25% by weight of    glycerol monostearate distributed substantially uniformly    throughout. Inserter B was subjected to plasma processing, but no    blooming processing.-   INSERTER C: molded from polypropylene including 0.25% by weight of    glycerol monostearate distributed uniformly throughout. Inserter C    was subjected to no plasma processing and to four (4) days of    blooming processing.-   INSERTER D: molded from polypropylene including 0.25% by weight of    glycerol monostearate distributed uniformly throughout. Inserter D    was subjected to plasma processing and one (1) day of blooming    processing.-   INSERTER E: same as Inserter D except subjected to plasma processing    and to two (2) days of blooming processing.-   INSERTER F: same as Inserter D except subjected to plasma processing    and to three (3) days of blooming processing.-   INSERTER G: same as Inserter D except subjected to plasma processing    and to four (4) days of blooming processing.

The plasma processing referred to above was performed using a PS-0150plasma unit at 25 watts power. The plasma gas included oxygen at a flowrate of 30-50 cc/min. The plasma pressure was 0.05 to 0.10 torr and thetime of plasma exposure was 90 minutes.

The blooming processing referred to above was performed by subjectingthe inserter to a temperature of 50° C. in air for the designated periodof time. In all cases in which plasma processing and blooming processingboth occurred, the plasma processing preceded the blooming processing.

A series of tests were run to evaluate the lubricity of the insertersprovided.

In each of the tests, the inserter rod was equipped with a soft distaltip molded from a silicone polymeric elastomer made from a formulationsold by NuSil Technology under the trademark Nusil 4516. These tips weresized and adapted to be received and held or trapped in the fold of anIOL being passed through an inserter.

Except for the presence of the tip and the use of the inserters notedabove, the system used in this testing was the IOL injector system soldby Allergan, Inc. under the trademark PIC 1. The lenses used in thetesting had varying optical powers and included optics made ofelastomeric silicone-based polymeric materials. Specifically the IOLswere those sold by Allergan, Inc. under the trademarks SI-30 and SI-40.

The test procedure used was as follows. The IOL was loaded into theloading chamber and the inserter was placed into the hand piece. Anamount of commercially available sodium hyaluronate-containing aqueoussolution approximately equal to the volume of the IOL optic wasdispensed into the loading chamber. In certain tests the IOL wasimmediately advanced through the entire forward tube and then out thedistal port. In other tests, the IOL was allowed to dwell in the loadingchamber (Stage 1) a period of time specified and then was advanced intothe forward tube. The IOL was allowed to dwell in the forward tube(Stage 2) for a specified period of time before being released out thedistal port. After the IOL was released, the rod and tip were cleanedwith water and the tip was reused up to five (5) times.

Results of these tests were as follows:

IOL POWER DWELL TIME⁽¹⁾ FORCE IOL INSERTER STYLE DIOPTERS STAGE 1/STAGE2 REQUIRED RELEASE A SI-40 16.5 TO 25 0.4/0.2 MIN. LENSES WOULD NOT MOVEB SI-40 16.5 TO 25 0.4/0.2 MIN. LENSES WOULD NOT MOVE C SI-40 16.5 TO 250.5/0.8 MIN. LENSES WOULD NOT MOVE D SI-30 21.5    0 MIN. MODERATE VERYWELL CONTROLLED D SI-40 21.5    5/2.8 MIN. FAIL ROD BYPASSED THE LENS ESI-40 16.5 0.4/0.2 MIN. MODERATE VERY WELL CONTROLLED E SI-40 20.00.4/0.2 MIN. MODERATE VERY WELL CONTROLLED TO HIGH E SI-40 24.5 0.4/0.2MIN. LOW TO VERY WELL CONTROLLED MODERATE F SI-40 16.5 0.4/0.2 MIN.MODERATE VERY WELL CONTROLLED F SI-40 20.5 0.4/0.2 MIN. MODERATE VERYWELL CONTROLLED F SI-40 25.0 0.4/0.2 MIN. MODERATE VERY WELL CONTROLLEDG SI-40 15.5 0.4/0.2 MIN. LOW TO VERY WELL CONTROLLED MODERATE G SI-4020.5 0.4/0.2 MIN. MODERATE VERY WELL CONTROLLED G SI-40 24.5 0.4/0.2MIN. MODERATE VERY WELL CONTROLLED ⁽¹⁾More than one test was run formany of the inserter/IOL style/power combinations. The dwell time wasoften varied from test to test. Thus, the dwell times are shown in termsof ranges of time.

These results indicate that Inserter A, even though it included 0.25% byweight of glycerol monostearate, is ineffective to insert IOLs in thetest conducted. In addition, Inserters B and C—which were subjected toeither plasma processing or blooming processing—but not both—areineffective to insert IOLs in the tests conducted. Further, InserterD—which was subjected to plasma processing and a limited amount ofblooming processing—is somewhat effective to insert IOLs in the testsconducted. However, Inserters E, F and G which were subject to bothplasma processing and substantial blooming processing are effective toinsert IOLs in the tests conducted.

The IOL inserter cartridges in accordance with the present inventionhave an enhanced ability to pass IOLs for insertion into the eye. Theenhanced lubricity of these cartridges, resulting from physicallyadmixed or combined oleophilic components, allows reduced force to beused to pass an IOL, relative to the force needed to pass an IOL througha cartridge without the oleophilic component. This reduced forcerequirement results in advantageously reducing the risk of harming thecartridge (inserter) and/or the IOL by passing an IOL through thecartridge. Thus, the relatively straightforward and uncomplicatedphysically admixing or combining of an oleophilic component into an IOLinserter provides a substantial and outstanding combination of benefits.

Comparable results are obtained using similar inserters andmethodologies in which the glycerol monostearate is replaced by aneffective amount of polyvinylpyrrolidone, a hydrophilic lubricityenhancing component.

A second series of IOL inserters, similar in configuration to inserter10, were provided and tested.

These inserters were molded from polypropylene including 0.25% by weightof glycerol monostearate distributed substantially uniformly throughout.These inserters were subjected to plasma processing using a PS-0150plasma unit at 500 watts power. The plasma gas included oxygen at a flowrate of 30-50 cc/min. The plasma pressure was 0.05 to 0.10 torr and thetime of plasma exposure was 2 minutes. Immediately after plasmaprocessing, the inserters were coated with an aqueous solutioncontaining 1% by weight of hydroxypropylmethylcellulose (HPMC). Theinserters were dried at 70° C. for 15 minutes.

The plasma processing, coating and drying steps were repeated exceptthat the plasma processing occurred for a period of 1 minute. Theinserters were then sterilized using ethylene oxide.

A series of tests, using the test-procedure outlined previously, wererun to evaluate, the lubricity of the inserters provided.

Results of these tests were as follows:

IOL POWER DWELL TIME FORCE IOL INSERTER STYLE DIOPTERS STAGE 1/STAGE 2REQUIRED RELEASE 1 SI-30 12    0 MIN. MODERATE CONTROLLED 2 SI-40 12 5/2MIN. LOW/MODERATE VERY WELL CONTROLLED 3 SI-40 12 5/5 MIN. LOW/MODERATEVERY WELL CONTROLLED 4 SI-40 12 5/8 MIN. LOW/MODERATE CONTROLLED 5 SI-4012 0/5 MIN. LOW/MODERATE VERY WELL CONTROLLED 6 SI-30 12    0 MIN.MODERATE CONTROLLED 7 SI-40 20 5/2 MIN. LOW/MODERATE CONTROLLED 8 SI-4020 5/5 MIN. LOW/MODERATE CONTROLLED 9 SI-40 20 5/8 MIN. LOW/MODERATECONTROLLED 10 SI-40 20 0/5 MIN. LOW VERY WELL CONTROLLED 11 SI-30 24   0 MIN. MODERATE VERY WELL CONTROLLED 12 SI-40 25 5/2 MIN. LOWCONTROLLED 13 SI-40 25 5/5 MIN. LOW/MODERATE VERY WELL CONTROLLED 14SI-40 25 5/8 MIN. LOW/MODERATE VERY WELL CONTROLLED 15 SI-40 25 0/5 MIN.LOW/MODERATE CONTROLLED

These results demonstrate that the inserters processed with plasma andHPMC have sufficient lubricity to facilitate the passage of an IOLthrough the inserter.

Comparable results are obtained with inserters being subjected to plasmaprocessing, as described with regard to the second series of tests,coating with an aqueous solution containing 2% to 3% by weight of HPMCand drying at 70° C. for 15 minutes on a one-time basis (as opposed tothe repeated plasma processing, coating and drying steps noted above).

While this invention has been described with respect of various specificexamples and embodiments, it is to be understood that the invention isnot limited thereto and that it can be variously practiced within thescope of the following claims.

1. A method of making an intraocular lens (IOL) insertion apparatuscomprising: providing a polypropylene insertion tube comprising a hollowtube having an interior wall defining a hollow space through which anintraocular lens is passed and an outlet through which said intraocularlens is passed from said hollow space into an eye; and securing acoating to said interior wall of said hollow tube, wherein the coatingcomprises polyvinylpyrrolidone, wherein the polyvinylpyrrolidone isphysically secured, other than by covalent bonding, to said interiorwall and is effective to facilitate the passage of said intraocular lensthrough said hollow space and into an incision of 3.5 mm or less.
 2. Themethod of claim 1, further comprising the step of exposing thepolypropylene insertion tube to plasma.
 3. The method of claim 2,wherein the polypropylene insertion tube is exposed to plasma before thecoating is secured to the interior wall.
 4. The method of claim 2,wherein the polypropylene insertion tube is exposed to plasma after thecoating is secured to the interior wall.
 5. The method of claim 1,wherein the hollow tube is tapered through at least a portion thereof.6. The method of claim 1, wherein the coating further comprises a secondpolymer component covalently bonded to the interior wall of the hollowtube.